An interventional study of KAWAI powder and Placebo in Cervical Cancer, sponsored by Obstetrics & Gynecology Hospital of Fudan University. Not yet recruiting. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Not applicable, Interventional, and Supportive care
This is a multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to evaluate whether an oral probiotic supplement (KAWAI inactivated bacteria) can reduce the side effects (especially diarrhea) caused by pelvic external beam radiation therapy in patients who have undergone surgery for cervical cancer.
Women aged 18 to 70 who have been diagnosed with cervical cancer, have recently undergone surgery, and are scheduled to receive only pelvic external radiation therapy may be eligible to participate. Participants will be randomly assigned (like flipping a coin) in a 1:1 ratio to receive either the KAWAI supplement or a placebo. They will take the study product starting 7 days before radiation therapy and continue until 6 weeks after the radiation therapy ends.
Researchers will closely monitor and compare the occurrence of diarrhea and other side effects between the two groups to see if the KAWAI supplement is safe and effective in improving patients' quality of life during radiotherapy. A total of 100 participants are expected to be enrolled.
Background and Rationale:
Pelvic external beam radiotherapy (EBRT) is a standard adjuvant treatment for post-operative cervical cancer patients. However, it often causes acute radiation-induced toxicities, particularly gastrointestinal reactions such as diarrhea, due to the disruption of intestinal and vaginal microecology. Pre-clinical and early clinical data suggest that probiotics, specifically KAWAI inactivated bacteria, may help maintain gut barrier integrity and modulate the immune response. This study aims to evaluate the efficacy and safety of oral KAWAI in reducing radiation-induced toxicities.
Study Design:
This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial. A total of 100 eligible patients will be randomized in a 1:1 ratio to either the KAWAI group (N=50) or the placebo group (N=50) using a Central Interactive Web Response System (IWRS).
Intervention:
Experimental Group: Oral KAWAI inactivated bacteria, 4g/day (2g in the morning on an empty stomach, 2g before dinner).
Placebo Group: Oral placebo, matching in appearance, color, smell, and packaging, administered twice daily.
Treatment Duration: Starting 7 days prior to the initiation of pelvic EBRT and continuing until 6 weeks after the completion of EBRT.
Objectives and Endpoints:
Primary Objective: To initially evaluate the efficacy of oral KAWAI in reducing the incidence of acute gastrointestinal toxicity (especially diarrhea) compared to placebo.
Primary Endpoint: The incidence of different grades of diarrhea during pelvic EBRT, assessed according to NCI-CTCAE v5.0.
Secondary Endpoints:
Incidence and severity of other radiotherapy-related adverse reactions (e.g., nausea, vomiting, radiation vaginitis, radiation cystitis).
Longitudinal changes in Quality of Life (QoL) assessed via EORTC QLQ-C30 and QLQ-CX24.
Safety and tolerability of oral KAWAI (incidence of AEs and SAEs).
Exploratory Endpoints:
Changes in gut and vaginal microbiota diversity and composition (via 16S rRNA sequencing).
Changes in systemic inflammatory markers (IL-6, TNF-α) and lymphocyte subsets (CD3+, CD4+, CD8+ T cells).
Inclusion/Exclusion Highlights:
Eligible patients are females aged 18-70 with histopathologically confirmed cervical cancer, post-surgery, requiring only pelvic EBRT (ECOG 0-1). Key exclusion criteria include prior radiotherapy, need for concurrent chemotherapy or brachytherapy, severe gastrointestinal diseases, recent use of probiotics/immunosuppressants, and active uncontrolled infections.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Obstetrics & Gynecology Hospital of Fudan University is the lead sponsor of 26 studies on the registry; 24 are open to participants now.
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Histopathologically confirmed cervical cancer, post-surgery, and evaluated based on postoperative pathology to require only pelvic external beam radiotherapy (EBRT).
performance status of 0-1.
Adequate major organ function.
Provision of written .
Exclusion Criteria:
High-risk factors in postoperative pathology such as positive margins requiring brachytherapy; or lymph node , parametrial invasion.
Requirement for concurrent chemotherapy during pelvic EBRT based on postoperative pathology.
Prior radiotherapy or pelvic .
Uncontrolled acute reproductive tract infection.
disease or use of systemic (>10 mg/day prednisone equivalent) or other immunosuppressants within 3 months.
Use of any probiotics (live or dead), prebiotics, or synbiotics within 1 month.
Allergy to probiotics or history of severe food allergy.
Severe heart, liver, kidney, or gastrointestinal diseases.
Participation in other clinical trials or receipt of drugs/vaccines within 30 days.
Other factors judged by the investigator that may affect study results or lead to early termination, such as alcoholism, drug abuse, severe comorbidities (including mental illness) requiring concurrent treatment, severe laboratory abnormalities, or family/social factors affecting subject safety.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive oral inactivated KAWAI bacteria. Dose: 4g/day (2 packets in the morning on an empty stomach, 2 packets before dinner before 4:00 PM). Administration starts 7 days prior to the initiation of pelvic external beam radiation therapy (EBRT) and continues until 6 weeks after the completion of EBRT.
Dietary Supplement: KAWAI powder
Participants receive oral placebo matching the KAWAI supplement in appearance, color, smell, packaging, and administration schedule. Dose: 2 packets twice daily (before 4:00 PM). Administration starts 7 days prior to the initiation of pelvic EBRT and continues until 6 weeks after the completion of EBRT.
Other: Placebo
Oral administration of inactivated KAWAI bacteria. Dose: 4g/day (4 packets) taken twice daily (2 packets in the morning on an empty stomach, 2 packets before dinner before 4:00 PM). Treatment starts 7 days prior to the initiation of pelvic external beam radiotherapy (EBRT) and continues until 6 weeks after the completion of EBRT.
Oral administration of placebo, matching the KAWAI supplement in appearance, color, smell, and packaging. Dose: 2 packets taken twice daily (before 4:00 PM). Administration starts 7 days prior to the initiation of pelvic EBRT and continues until 6 weeks after the completion of EBRT.
Incidence of Diarrhea (NCI-CTCAE v5.0)
To evaluate the incidence of different grades (1-4) of diarrhea during pelvic external beam radiation therapy in postoperative cervical cancer patients. Severity and frequency will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time frame: From the initiation of pelvic external beam radiotherapy (EBRT) to 6 weeks after the completion of EBRT.
Incidence and Severity of Other Radiation-Induced Toxicities
Incidence and severity (Grades 1-4) of other acute radiation-related adverse reactions, including nausea, vomiting, oral mucositis, radiation vaginitis, and radiation cystitis, assessed according to NCI-CTCAE v5.0.
Time frame: From the initiation of pelvic external beam radiotherapy (EBRT) to 6 weeks after the completion of EBRT.
Quality of Life (QoL) Scores
Longitudinal changes in Quality of Life scores, assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and the cervical cancer-specific module (QLQ-CX24).
Time frame: Baseline (Day 0), end of EBRT (Week 6), and 3 months after completion of radiotherapy.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence, severity, and relationship to the study treatment of all Adverse Events (AEs) and Serious Adverse Events (SAEs), evaluated according to NCI-CTCAE v5.0.
Time frame: From the time the informed consent is signed until 30 days after the last dose of the study treatment.
Changes in Gut/Vaginal Microbiota and Inflammatory Markers
Exploratory endpoints include changes in the diversity and composition of gut and vaginal microbiota (assessed via 16S rRNA sequencing) and changes in serum inflammatory markers (IL-6, TNF-α) and lymphocyte subsets (CD3+, CD4+, CD8+ T cells) at specific time points before, during, and after treatment.
Time frame: Baseline (Day 0), during EBRT (Week 3), and 3 months after radiotherapy completion.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's planned 14 months is below that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Obstetrics & Gynecology Hospital of Fudan University